The Molnár-Institute visited the 25th meeting of the American Association of Pharmaceutical Scientists. The interesting scientific program included a very informative “Quality by Design for Analytical Methods” session supported by Pfizer. The speakers were Tim Graul (Pfizer), Brent Harrington (Pfizer), Yubing Tang (FDA) and Jennifer McCafferty (GSK).
Want to tell your team about the benefits of DryLab? Is it tricky to get everyone together in one place for a presentation? You can now request DryLab presentations over the web. Up to 10 different computers can take part in the webinar, so your whole team can join in from their own workplace.
Interested? Contact us about setting up your DryLab webinar presentation: info@molnar-institute.com
A: 10% of pharma production worldwide is burned each year due to quality problems. This corresponds to roughly 10% of 800 billion US $, which is 80 billion $. Using DryLab we can save a large part of this by making sure that we use robust methods.
Methods are often not robust because several factors are slightly changing at the same time, causing non-compliance with existing methods. To make sure that set points are situated in the correct position, we developed an incredible algorithm, which runs for example for 5 factors at 3 levels, 3^5 = 243 runs in less than 1 minute, around the set point. This enables you to save days and weeks in your validation work.
For further information, contact us.
Molnár-Institute will be exhibiting at the following upcoming conferences. We will be demonstrating DryLab® 2010, and our scientists will be on-hand to discuss your questions and experiences with DryLab in-depth. Please stop by. We would love to talk with you!
Check back for booth locations and details on DryLab-related presentations.
Pittcon 2012: 11–15 March, Orange County Convention Centre, Orlando, Florida, USA. Pittcon is the world’s largest annual conference and exposition for laboratory science. Pittcon 2012 will offer the latest technology and instrumentation from nearly 1,000 exhibitors, a diverse technical program of more than 2,000 technical presentations, 90-plus short courses to enhance your educational experience, and networking sessions that provide the chance to exchange innovative ideas with scientists from around the world.
Analytica 2012: 23rd International Trade Fair for Laboratory Technology, Analysis, Biotechnology and Analytical Conference, 17–20 April, New Munich Trade Fair Centre, Munich, Germany. .
ACHEMA 2012: 18–22 June, Frankfurt am Main, Germany. ACHEMA is the world forum of the process industry and the trend-setting technology summit for chemical engineering, environmental protection and biotechnology. The 30th ACHEMA will again be the leading international meeting point for decision-makers and experts from all related industries.
HPLC 2012: 38th International Symposium on High PerformanceLiquid Phase Separations and Related Techniques, 16–21 June, Anaheim Marriott, Anaheim, California, USA. The HPLC conference is the largest meeting in the world dedicated to liquid phase separation science. This international meeting series is multi-disciplinary in nature and brings together many of the world’s leading authorities to address the practical and economical issues and challenges related to all aspects of liquid phase separation science techniques. The conference will be comprised of plenary and keynote lectures, prominently featured poster presentations, and the largest, most comprehensive display of commerical products related to liquid phase separations and analysis.
Kate Monks presented a talk titled QbD for HPLC – Method Transfer Challenges at Separation Science Europe 2011, October 10–11, at The Royal Institution in London, England, UK.
Abstract:
Transferring methods across continents, a number of problems are typically encountered. In the global economy where products and their HPLC methods are distributed worldwide, there are often discrepancies between the original method and its local variant. Due to these and other problems in method transfer, the regulatory authorities (FDA, ICH, etc.) are nowadays requiring a more systematic approach to HPLC method development. This presentation shows how to apply Quality by Design (QbD) principles to the development of HPLC methods focusing on method understanding and good science. It will be shown how modeling creates a platform for Control Strategy and Design Space, also helping to visualize robustness in a unique way. This provides a deep chromatographic understanding and the necessary QbD framework for HPLC, achieving optimal robust methods in a transparent and demonstrable way.
For a copy of this presentation contact: kate.monks@molnar-institute.com
DryLab® 25th Anniversary Workshop: 1–2 September 2011 in Berlin, Germany
The 25 years of DryLab® HPLC method development software and 30 years of the Molnár-Institute were celebrated in an informative and lively workshop in early September. The workshop covered the use of DryLab in daily laboratory practice, the continuing improvement of HPLC methods toward more flexibility in the Quality by Design movement, and the visualization of the Design Space for the development of more robust HPLC methods. The event was supported by discussions and exchange of experiences with many DryLab users from a number of pharmaceutical companies and leading university experts.
We are thankful to all of those who took part, and special thanks go to the speakers:
- Prof. Dr. Tomasz Baczek, Medical University, Gdansk, Poland:
“Chemometric evaluation of chromatographic retention in view of optimization of liquid chromatography separations supported by DryLab® software”
- Dr. Alexander Buske, Jenapharm GmbH & Co. KG, Jena, Germany:
“Dimensions in method development”
- Dr. Barbara Channer, Actelion Pharmaceuticals Ltd., Allschwil, Switzerland: “Aspects of HPLC method development in the pharmaceutical industry”
- Dr. Björn Thoralf Erxleben, Shimadzu Europe, Duisburg, Germany:
“Method transfer to UHPLC – A chance to reconsider and optimize methods, but really taken?”
- Prof. Dr. Jenö Fekete, University of Technology & Economics, Budapest, Hungary:
“Selection of proper stationary phase for optimization of reversed phase separation using DryLab® 2010 intelligent optimization software package”
- Dr. Katalin Ganzler, Gedeon Richter, Budapest, Hungary:
“DryLab® as a learning tool in an analytical laboratory”
- Dr. Winfried Haumesser, formerly Bayer AG, Berlin, Germany:
“Competitiveness and HPLC in pharma production”
- Dipl.-Ing. Norbert Klapczynski, Molnár-Institute, Berlin, Germany:
“DryLab® version 4.0, installations and new windows management”
- Dr. Imre Molnár, Molnár-Institute, Berlin, Germany:
“QbD for HPLC method transfer challenges”
- Dipl.-Chem. Kate Monks, Molnár-Institute, Berlin, Germany:
“Applications of DryLab® in HPLC method development according to QbD principles”
- Dr. Hans-Jürgen Rieger, Molnár-Institute, Berlin, Germany:
“Automated Method Development for HPLC methods according to Quality by Design considerations”
- Dr. Gesa Schad, HiChrom, Theale, United Kingdom:
“Evolution of computer-assisted method development and optimization in liquid chromatography”
- Francois Vogel, Novartis AG, Basel, Switzerland: “DryLab® in Novartis development and its use for robust LC-methods”
With DryLab 2010 HPLC input experiments can be carried out in an automated fashion overnight using the following chromatographic data systems:
- Shimadzu LabSolution
- Agilent ChemStation
- Dionex Chromeleon
Communication with other data systems is under construction.
If you would like to try this functionality out, let us know!
A: Recently, Ron Majors wrote an important article in LCGC about how to switch from older columns to more modern ones with smaller particles, which addresses the need of those who want to take advantage of the newest technologies in columns for faster analysis.
He mentions a number of different software programs that can help you to evaluate such transitions; among them is DryLab 2010. DryLab, in addition to calculating the effect of column dimensions and particle size, also allows the adjustment of selectivity by modeling the gradient shape, flow rate, pH, temperature, ternary composition, and dwell volume; and it visualizes robustness in a graphical way. DryLab can calculate critical resolution values for 5 factors and 3 levels, 243 experiments in just 1 minute, showing how robust the working point has been selected.
It is very important, when using any of the mentioned calculators, to make sure that both columns (old and new) have the same packing material, which usually is not the case. If they are not, this can lead to unexpected changes in selectivity, which the chromatographer may end up trying to compensate for over many weeks and months. With DryLab you can avoid confusion and loss of time.
A: For an HPLC method to be robust, all compounds of interest must first be well separated. This is carried out with the help of DryLab. Once a working point has been located, we can vary all important factors (for example gradient time, temperature, pH, ternary composition, start %B, end %B, flow rate, dwell volume, etc.) at the same time for any combination of tolerance limits. This is done either experimentally in weeks and months or with the help of the wonderful novel DryLab Robustness Module, in minutes.
If you would like to test the robustness of your method, let us know!
A: Recently, the modeling capabilities in DryLab have been extended into a further dimension: you can now model 3 parameters (gradient time, temperature, ternary eluent composition or gradient time, temperature, pH) at the same time. Resolution maps for these cases are 3D cubes, which can be scrolled through and rotated at will.
